AdRes Srl, Turin, Italy.
Am J Cardiovasc Drugs. 2009;9(6):383-92. doi: 10.2165/11315730-000000000-00000.
To evaluate the cost effectiveness and cost utility of the use of valsartan in addition to standard therapy for the treatment of patients with chronic heart failure with low left ventricular ejection fraction (LVEF). The study was conducted by means of a cohort simulation based on a probabilistic Markov model and projecting the 23-month follow-up results of the Val-HeFT (Valsartan Heart Failure Trial) study over a 10-year time horizon. The model included four states (New York Heart Association [NYHA] classes II, III, IV, and death), and had a cycle duration of 1 month. Probabilistic simulations were performed using the WinBUGS software for Bayesian analysis. The distribution of patient parameters (sex, age, use of beta-adrenoceptor antagonists, and ACE inhibitors) in the simulated population were derived from the Italian heart failure patient population. Individual mortality data were derived from general mortality data by multiplying by a NYHA state-specific relative risk, while the probability of changing NYHA class was taken from the Val-HeFT data. Costs (2007 values) were calculated from the perspective of the Italian Health Service (IHS) and included costs for drugs and heart failure hospitalizations. Quality-of-life (QOL) weights were obtained by using published health-related QOL data for heart failure patients. A 3.5% annual discount rate was applied. Probabilistic sensitivity analysis was performed on each parameter using original-source 95% confidence interval (CI) values, or a +/-10% range when 95% CI values were unavailable. For the 10-year time horizon, patients were estimated to live for an average of 2.3 years or 1.7 quality-adjusted life-years (QALYs), with slight increases in the valsartan group. In this group, hospitalizations for worsening heart failure were predicted to be significantly reduced and overall treatment costs per patient to decrease by about and U20AC;550. In subgroup analyses, valsartan lost dominance in patients in NYHA II, and in those receiving beta-adrenoceptor antagonists or ACE inhibitors; the mean incremental cost-utility ratio for these groups was 21 240, 129 200, and 36 500 and U20AC;/QALY, respectively. Valsartan in addition to standard therapy is predicted to dominate standard therapy alone in Italian patients with mild to severe heart failure and low LVEF. There are relevant differences among various patient subgroups, and valsartan is expected to be good value for money particularly in the treatment of the most severe and less intensively treated (no ACE inhibitors, no beta-adrenoceptor antagonist) heart failure patients.
评估缬沙坦联合标准疗法治疗低左心室射血分数（LVEF）慢性心力衰竭患者的成本效果和成本效用。该研究通过基于概率马尔可夫模型的队列模拟进行，将 Val-HeFT（缬沙坦心力衰竭试验）研究的 23 个月随访结果投影到 10 年时间范围内。该模型包括四个状态（纽约心脏协会[NYHA]心功能 II、III、IV 级和死亡），周期持续时间为 1 个月。使用 WinBUGS 软件进行贝叶斯分析的概率模拟。模拟人群中患者参数（性别、年龄、β-肾上腺素受体拮抗剂和 ACE 抑制剂的使用）的分布来自意大利心力衰竭患者人群。个体死亡率数据通过乘以 NYHA 特定相对风险来从一般死亡率数据中得出，而 NYHA 级别变化的概率则取自 Val-HeFT 数据。（2007 年）成本从意大利卫生服务机构（IHS）的角度计算，包括药物和心力衰竭住院费用。使用已发表的心力衰竭患者健康相关生活质量（QOL）数据获得 QOL 权重。应用 3.5%的年度贴现率。使用原始来源的 95%置信区间（CI）值或当 95%CI 值不可用时为 +/-10%范围对每个参数进行概率敏感性分析。在 10 年时间范围内，预计患者的平均生存时间为 2.3 年或 1.7 个质量调整生命年（QALY），缬沙坦组略有增加。在该组中，预计心力衰竭恶化的住院治疗将显著减少，每位患者的总体治疗成本将减少约 550 欧元。在亚组分析中，在 NYHA II 级的患者和接受β-肾上腺素受体拮抗剂或 ACE 抑制剂的患者中，缬沙坦失去了优势；这些组的平均增量成本-效用比分别为 21240、129200 和 36500 欧元/ QALY。在意大利有轻度至重度心力衰竭和低 LVEF 的患者中，缬沙坦联合标准疗法预计将优于单独标准疗法。在各个患者亚组中存在明显差异，缬沙坦在治疗最严重和治疗强度最低（无 ACE 抑制剂、无β-肾上腺素受体拮抗剂）的心力衰竭患者方面预计具有良好的性价比。
